CRA I

Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID: 25109851

This Clinical Research Associate (CRA I) role involves overseeing the integrity of clinical research studies by conducting site qualifications, monitoring, and ensuring compliance with regulatory and protocol standards.

Job Responsibilities

• Perform site qualification, initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, Good Pharmacoepidemiological Practices (GPP) and protocol compliance; evaluate overall site performance, recommend actions and develop action plans.
• Verify informed consent procedures are adequately performed and documented; protect confidentiality; assess factors that might affect subject safety and data integrity.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP):
  • Assess site processes.
  • Conduct source document review of site records and medical documents.
  • Verify required clinical data entered in the case report forms (CRFs) is accurate and complete.
  • Apply query resolution techniques remotely and on site, guiding staff to closure within agreed timelines.
  • Utilize available hardware and software to support effective data review and capture.
  • Verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation, storage and security reviews; verify IP dispensation and administration, and manage risks related to blinded or randomized IP information.
• Review Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile with Trial Master File (TMF); ensure archiving of essential documents per local guidelines.
• Document activities via letters, trip reports, communication logs and other required project documents; support recruitment, retention and awareness strategies; enter data into tracking systems to monitor observations and actions.
• Manage site‑level activities and communications to meet project objectives, deliverables, and timelines; adapt quickly to changing priorities under Lead CRA oversight.
• Act as primary liaison with site personnel or in collaboration with another CRA or Central Monitoring Associate; ensure training and compliance of site staff.
• Prepare for and attend investigator and sponsor meetings; participate in global clinical monitoring/project staff meetings; attend required training sessions.
• Provide guidance on audit readiness standards and support audit preparation and follow‑up actions.
• For Real World Late Phase, use the business card title of Site Management Associate I and perform additional responsibilities including:
  • Site support throughout the study lifecycle from identification through close‑out.
  • Knowledge of local requirements for real‑world late‑phase study designs.
  • Chart abstraction activities and data collection.
  • Collaboration with sponsor affiliates, medical science liaisons and local country staff.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICh Guidelines and other applicable regulatory requirements.
• Demonstrated strong computer skills and ability to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.
• US ONLY: May be deployed to sites requiring specific medical and personal information to gain facility access. Compliance with site requests may be required to maintain employment.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate, to assist employees or applicants to perform the essential functions of the job. Furthermore, the Company complies with the EU Equality Directive and maintains equal employment opportunity in all jurisdictions at which it operates.